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A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty

Sponsor
Zimmer Biomet (Industry)
Overall Status
Completed
CT.gov ID
NCT00757354
Collaborator
Biomet U.K. Ltd. (Industry)
77
Enrollment
1
Location
1
Arm
21
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Metal on Metal cementless hip
 N/A

Detailed Description

This evaluation is being conducted to investigate the extent of metal ion release and its incorporation into the surrounding tissue resulting from metal on metal articulating surfaces in cementless total hip arthroplasty.

The amount of metallic ions released post operatively will be assessed by the concentration of Cobalt, Chromium and Molybdenum present in urine and analysed by I.C.P.M.S. (Inductive Coupled Plasma Mass Spectroscopy). The amounts of metallic ions released will be related to the hip function and range of motion measured pre-operatively and post-operatively. Secondary performance of the metal-on-metal articulation will be determined by radiographic evaluation and incidence of complications / revision rates.

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metal on Metal cementless hip

Metal on Metal cementless hip arthroplasty

Procedure: Metal on Metal cementless hip
Metal on Metal hip arthroplasty
Other Names:
  • metal on metal hip arthroplasty

    		•

    Outcome Measures

    Primary Outcome Measures

    1. concentration of Cobalt, Chromium and Molybdenum ions in urine [various follow-up visits]

    Secondary Outcome Measures

    1. harris Hip Score, oxford hip, WOMAC and SF-12 [various follow-up visits]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects selected for this Evaluation will be grouped by initial diagnosis into one of the following diagnostic groups:

    • Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.

    • Rheumatoid arthritis.

    • Selection of subjects for this Evaluation should include the following considerations:

    • Patients under 70 years of age.

    • Willing to return for follow-up evaluations.

    • No bias to sex.

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Avon Orthopaedic Centre Bristol United Kingdom

    Sponsors and Collaborators

    • Zimmer Biomet
    • Biomet U.K. Ltd.

    Investigators

    • Principal Investigator: Evert J Smith, FRCS, Avon Orthopaedic Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT00757354
    Other Study ID Numbers:
    • BMETEU.CR.EU46
    First Posted:
    Sep 23, 2008
    Last Update Posted:
    Jun 19, 2017
    Last Verified:
    Jun 1, 2017
    Additional relevant MeSH terms:
    Arthritis
    Necrosis

    Study Results

    No Results Posted as of Jun 19, 2017